Dexmedetomidine vs Lorazepam for Agitation in Schizophrenia or Bipolar Disorder

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Temple University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

Eligibility Criteria

Adults aged 18-55 with schizophrenia, schizoaffective disorder, or bipolar disorder experiencing moderate to severe agitation can join. They must be inpatients at Episcopal Hospital, not allergic to the study drugs, and not on high-risk medications or have certain health conditions like severe liver issues or heart problems.

Inclusion Criteria

I am currently admitted as an inpatient at Episcopal Hospital.

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

I am between 18 and 55 years old.

I am experiencing a moderate to severe episode of agitation.

Exclusion Criteria

I am not pregnant or breastfeeding.

I have liver problems.

I have lung disease and am on treatment like oxygen or inhalers.

I have had low potassium or magnesium levels in the last 2 years.

I am currently taking medications that are considered high-risk, such as opioids or drugs that can affect my heart rhythm.

I am currently taking benzodiazepines or methadone regularly.

I have a history of heart rhythm problems or a QTc of 500 msec or more.

Participant Groups

The trial is testing sublingual dexmedetomidine against lorazepam for calming patients with significant agitation due to mental health conditions. The effectiveness will be measured using specific scales that assess excitement and calmness levels.

2Treatment groups

Experimental Treatment

Active Control

Group I: DexmedetomidineExperimental Treatment1 Intervention

Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.

Group II: LorazapemActive Control1 Intervention

Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.